Vanrx Pharmasystems Inc.

Christopher Procyshyn

Ross M Gold

Jeroen Immerzeel

Steve Sang Joon Park

Marcin Czeslaw Cichy

Juvenal Naing

John Senger

Nick Broadbent

Paul Nowakczyk

Steve Sang Joon

Paul Nowaczyk

An apparatus and method are presented for removing container covers within a controlled environment enclosure without using gloves. The apparatus comprises an articulated arm apparatus and a gripping apparatus and can further comprise a controller. The articulated arm apparatus can be configurable for holding and moving a container in three dimensions; and the gripping apparatus can be configured for gripping a container cover sealing the container. The method comprises moving the container using the articulated arm apparatus while holding a gripping area of the container cover substantially stationary using the gripping apparatus. The apparatus can further comprise a sensor configured for supplying information to the controller for determining the location of the container cover gripping area and an orientation of the container cover. The method can further comprise inspecting the container cover using the sensor. The container can be moved along a path and within a space determined by the controller.

Cover removal system for use in controlled environment enclosures

In one general aspect, a method for filling multiple containers with a pharmaceutical product is disclosed, which comprises decontaminating sealed nested materials in a transfer chamber, removing from the sealed nested materials one or both of a container nest holding the multiple containers and a closure nest holding multiple closures, transferring from the transfer chamber to a controlled environment enclosure the removed nest, aseptically filling the containers with the pharmaceutical product, and closing the containers with the multiple closures. The nests are configured to allow multiple closures and containers to be simultaneously aligned concentrically, and closed simultaneously. Spring-loaded retaining structures on the closure nest allow it to releasably retain multiple closures above the corresponding multiple containers. In some embodiments the spring-loaded features are monolithically integrated with the closure nest. The product may be lyophilized in partially sealed containers while the sealing closures are releasably retained by the closure nest.

Closure nest for releasably retaining a plurality of pharmaceutical container closures

Systems and methods permit gloveless filling containers with a product. A filling arm is disposed within the chamber. An optical sensor is configured to locate and target openings of the containers within the chamber. Locations of the openings are used to guide the filling arm to fill the containers with a product.

Robotic filling systems and methods

A controlled environment enclosure comprises a robotic arm manipulation system used to protect and unprotect a fluid path and a swab within the controlled environment enclosure. The apparatus allows the fluid path to be protected against dangerous decontamination vapors and chemicals before the controlled environment enclosure is decontaminated. The apparatus allows the fluid path to be unprotected without the use of gloves or other means that degrade the integrity of the controlled environment enclosure when decontamination is completed. The apparatus and method allow for the protecting, unprotecting and decontaminating sequences to be automated. In some embodiments the fluid path comprises a fill needle that can removably and aseptically be sealed with a disposable monolithic injection moulded polymeric fill needle sheath. The apparatus and method further allow for the use of a swab disposed in a swab holder that is aseptically and removably sealable to a swab cap to protect the swab against decontamination vapors.

Method for protecting and unprotecting the fluid path in a controlled environment enclosure

An apparatus and method are presented for removing container covers within a controlled environment enclosure with pre-sterilized nested containers without using gloves. The apparatus comprises an articulated arm apparatus and a gripping apparatus for the pre-sterilized nested containers and can further comprise a controller. The articulated arm apparatus can be configurable for holding and moving a container in three dimensions; and the gripping apparatus can be configured for gripping a container cover sealing the container. The method comprises providing the pre-sterilized nested containers in the form of a container having a plurality of decontaminated parts, moving the container using the articulated arm apparatus while holding a gripping area of the container cover substantially stationary using the gripping apparatus. The apparatus can further comprise a sensor configured for supplying information to the controller for determining the location of the container cover gripping area and an orientation of the container cover. The method can further comprise inspecting the container cover using the sensor. The container can be moved along a path and within a space determined by the controller.

Disclosed are systems and methods for aseptically filling pharmaceutical containers with a pharmaceutical substance and then lyophilizing it. In one general aspect, the system and method can employ a lyophilizer loader subsystem having an interior chamber in communication with an interior chamber of a lyophilizer subsystem via a portal with a sealable door, with the collective interior being aseptically sealable. An articulated robotic arm can be employed to batch transfer to the lyophilizer subsystem container nests bearing the pharmaceutical containers. In one embodiment, the nests may be transferred serially to the loader subsystem, with the articulated robotic arm being configured to transfer the nests of containers in batches to the lyophilizer subsystem. The articulated robotic arm can also be configured to be used to move batches of nests within the lyophilizer subsystem. One implementation includes two articulated arms and a joint rotary wrist driven by two rotary shoulders.

Method and apparatus for loading a lyophilization system

Systems and methods for aseptically filling pharmaceutical containers with pharmaceutical fluid are disclosed. In one general aspect, these are based on an aseptically sealable chamber that includes a transfer wall to which pre-sealed pharmaceutical source and receiving containers are mounted aseptically. A robotic arm and a syringe store are disposed within the chamber along with a sterilizing facility for establishing in the chamber an aseptic condition. The robotic arm can grip and operate syringes to inject and/or extract pharmaceutical products from the containers by piercing their closures with the needles of the syringes.

Apparatus and method for aseptically filling pharmaceutical containers with a pharmaceutical fluid using rotary stage

Method, device and system for filling pharmaceutical containers

Method for filling pharmaceutical containers

A controlled environment enclosure comprises a robotic arm manipulation system used to protect and unprotect a fluid path within the controlled environment enclosure. The apparatus allows the fluid path to be protected against dangerous decontamination vapors and chemicals before the controlled environment enclosure is decontaminated, the method not requiring the use of gloves or other means that degrade the integrity of the controlled environment enclosure. The apparatus similarly allows the fluid path to be unprotected for use without the use of gloves, the method not requiring the use of gloves or other means that degrade the integrity of the controlled environment enclosure when decontaminated is completed. The apparatus and method allow for the protecting, unprotecting and decontaminating sequences to be automated.

A hermetically sealed multi-axis articulated arm apparatus for use within a sealable isolator chamber is disclosed. In one general aspect, it comprises a rotational shaft that passes through an opening in the chamber, a sealing member disposed within the chamber for sealing the shaft to an inner surface of the chamber, interconnected hermetically sealed arm segments operably attached to the linear motion shaft; an end effector operably attached to a terminal arm segment among the arm segments, and at least one fully enclosed drive system for driving and controlling the shaft and the arm segments. The rotational shaft can further be a linear motion shaft for which the sealing member is a bellows. The materials for the parts of the apparatus exposed to the atmosphere of the chamber can be compatible with an aseptic and cleanable environment and the surfaces of the arm segments can be shaped to avoid pooling of contaminants.

Growing community of inventors

Surrey, Canada

Christopher Procyshyn